The industry type of medical devices belongs to the biomedical industry.
Medical devices are instruments, equipment, appliances, materials or other items, including required software, used alone or in combination in the human body; their use on the human body surface and in the body is not obtained by pharmacological, immunological, or metabolic means, but there may be a participation of these means and play a certain supporting role; and their use is intended to achieve the following intended purposes:
(a) prevention, diagnosis, treatment, monitoring, and alleviation of disease. p>
(i) The prevention, diagnosis, treatment, monitoring, and mitigation of disease.
(ii) The diagnosis, treatment, guardianship, mitigation, and compensation for injury or disability.
(iii) The study, substitution, and regulation of anatomical or physiological processes.
(iv) Pregnancy control.
Classification
China's current Regulations on the Supervision and Administration of Medical Devices stipulate that medical devices are managed in three categories.
The first category refers to medical devices whose safety and effectiveness are sufficiently ensured through routine management. Such as: basic surgical instruments (knife, scissors, pliers, tweezers, etc.), general diagnostic instruments (stethoscope, percussion hammer, reflective instruments, etc.), medical radiation protection and bandages, ointments and so on. Open the first class of medical equipment production, business enterprises in the provincial bureau for the record, do not need to apply for a license. Production of Class I medical devices to be in the local municipal drug supervision department for the production of registration certificates.
The second category refers to its safety, effectiveness should be controlled medical devices. Such as: medical electronic equipment (heart, brain diagnostic equipment, non-invasive monitoring equipment, etc.), B-type ultrasound diagnostic equipment, clinical testing and analysis of some of the instruments, as well as thermometers, sphygmomanometers and so on. It should be noted that the state has been part of the second class of medical devices into the business license is not required to operate the product.
such as: thermometers, sphygmomanometers, medical cotton wool, cotton gauze, sanitary masks, blood glucose meters, blood glucose test strips, pregnancy diagnostic test strips (early pregnancy test side test strips), condoms and so on. To open the second class of medical equipment production and operation enterprises to be in the provincial bureau for the production and operation of enterprise license, the production of the second class of medical equipment to be in the provincial bureau for the production of the certificate of registration.
Class III refers to medical devices that are implanted in the human body; used to support and sustain life; and potentially dangerous to the human body, the safety and effectiveness of which must be strictly controlled.
such as: extracorporeal circulation and blood processing equipment, implantable materials and artificial organs, medical polymer materials and products in the disposable blood transfusion, infusion set, injection puncture instruments in the disposable syringe, corneal contact lenses and so on. To start the third class of medical equipment production and operation of enterprises in the provincial bureau for the production and operation of enterprise licenses, the production of third class of medical devices in the national bureau for the production of registration certificates.